Chapter 2

The Philosophy and Guiding Principles for Effective FMEAs

In matters of style, swim with the current; in matters of principle, stand like a rock.

—Thomas Jefferson

IN THIS CHAPTER

One of the keys to effective Failure Mode and Effects Analyses (FMEAs) is for the entire FMEA process to be driven by the correct philosophy, meaning that the approach is based on the vital few guiding principles that support achieving high reliability in today’s competitive environment. This chapter lays out the primary focus areas for doing timely FMEAs effectively. The remaining chapters in this book build on these guiding principles.

2.1 WHAT IS PHILOSOPHY AND WHY DOES IT MATTER TO FMEAs?

We are boxed in by the boundary conditions of our thinking.

—Albert Einstein

Philosophy is a theory or attitude that guides one’s behavior. FMEA is a tool that exists in the larger framework of quality and reliability processes. If one’s approach to achieving quality and reliability is sound, then it will properly guide the use of the FMEA tool. Basing one’s approach to FMEAs on wrong principles, such as fixing existing problems rather than anticipating and preventing them, or on incorrect objectives, such as “to fill out a form” or “to comply with a mandate,” will reap unsatisfactory results.

The guiding principles below originate from the overall philosophy of FMEA as communicated in the Introduction to this book. Again:

Through the synergy engendered by the right team of experts, and by implementing correct and proven methods and procedures, problems can be anticipated and prevented resulting in safe and trouble-free products and processes, with the inherent risk in any system or process reduced to a very low level.

2.2 GUIDING PRINCIPLES FOR EFFECTIVE FMEAs

Each of the following is an important guiding principle, applicable to any type of FMEA, which should direct the FMEA process and FMEA practitioners. The remainder of this book embraces these principles.

2.2.1 Having the Right Objectives

If you don’t know where you are going, you will wind up somewhere else.

—Yogi Berra

Focus on Problem Prevention 

Preventing problems saves money and improves products. Fixing problems is necessary when they occur, but is substantially more expensive than problem prevention. There is a different mindset in an organization that focuses on problem prevention, and the tools and timing are different. FMEA is a key tool to prevent problems before designs reach testing or processes reach the plant floor, and to improve tests and controls to be sure problems do not reach consumers. The emphasis for this entire book is problem prevention.

Focus on Design and Process Improvements 

In order to achieve safe and reliable product and process designs in a timely manner, it is essential for FMEAs to drive design and process improvements as the primary objective. Safe and trouble-free designs and stable, capable, and error-proof manufacturing processes must be the primary goal. FMEAs need to drive action strategies that improve designs and processes. Chapter 7 describes many action strategies that can be employed to improve designs and processes, and reduce risk to a very low level.

Leverage FMEAs to Improve Test Plans and Process Controls 

Effective product testing and manufacturing process controls are essential elements of successful product development. Tests and process controls must accurately detect all possible failures and their causes based on the entire range of operating profiles and customers usages. FMEAs can and should improve test plans and process controls. Chapter 6 shows how FMEAs link to design verification and process controls.

Select FMEA Projects Based on Preliminary Risk Assessment 

FMEAs take time and cost money. It is not possible to perform FMEAs on every subsystem and component. A company should use the FMEA tool for projects that present a threshold level of risk based on a preliminary risk assessment. Chapter 4, Section 4.2, explains how to select FMEA projects.

Keep It Simple 

Some FMEA practitioners complicate FMEAs with extraneous and nonvalue information. Columns can be added to FMEAs that may seem like a good idea, but add time without corresponding value. Risk ranking scales can have too many ranking levels and complex criteria that lack clarity. Each and every worksheet column, scale, preparation task, and procedure step must pass this simple test: does it add sufficient value to justify the time that is expended? One of the overriding principles of effective FMEAs is to keep to the essential elements. This book intends to empower FMEA practitioners with knowledge about all aspects of FMEAs so they can make the right choices at each stage and keep the procedure as simple as possible.

2.2.2 Having the Right Resources

When every physical and mental resource is focused, one’s power to solve a problem multiplies tremendously.

—Norman Vincent Peale

FMEA Is a Team-Based Activity 

To be successful, FMEAs need the right team of subject matter experts. Even the best engineers have blind spots and only a team composed of the right disciplines can provide the necessary input and discussion to ensure all concerns are surfaced and addressed. FMEAs should not be performed by one or two individuals, or with the wrong team composition. Chapter 5, Section 5.3.4, provides guidance in establishing the correct FMEA team and ensuring they are properly trained.

Fully Understand the Basics of FMEAs 

There is no shortcut to understanding the definitions and concepts of FMEAs. Knowing the basics of FMEAs, such as key definitions and concepts, is essential for learning the proper application of FMEAs to achieve safe, reliable, and economical products and processes. FMEA teams need to be well trained on the fundamentals of FMEA and the correct procedures. Chapter 3 covers all of the key definitions, with many real-world examples.

Provide Skilled FMEA Facilitation and Unleash FMEA Team Creativity 

The skill set needed to perform FMEAs is not the same as the skill set needed to facilitate FMEA projects. Good facilitation is crucial for attaining the best results from FMEA teams, shortening FMEA in-meeting time, and maximizing the contributions from subject matter experts. Chapter 10 outlines and explains the unique skills for facilitating successful FMEA projects.

Albert Einstein said, “I am enough of an artist to draw freely upon my imagination. Imagination is more important than knowledge. Knowledge is limited. Imagination encircles the world.” When he said that, he certainly did not mean knowledge is not important. What he meant is that creativity and imagination play significant roles in developing new technology, new products, and new solutions. Many high-risk problems require thinking “outside the box,” and the FMEA team can solve very difficult problems when a skilled facilitator energizes its power of creativity. Chapter 10 covers how to facilitate productive FMEA meetings, unleash creativity, and move the team through the FMEA process to excellent results in a timely manner.

Benefit from Real-World Lessons Learned 

FMEA has been around for over 50 years and there have been many important lessons learned. Based on the knowledge from thousands of FMEAs and hundreds of companies, certain mistakes are seen to occur repeatedly. FMEA practitioners should not keep repeating these same mistakes. Chapter 9 reveals the most common FMEA mistakes and tells how to translate them into FMEA quality objectives so that results are uniformly exceptional. This chapter also describes an FMEA audit process based upon the FMEA quality objectives.

Another part of lessons learned is the field problems discovered after an FMEA analysis has been completed. No company has ever introduced products with no field problems or failures. An effective process must be in place to capture the test and field failures missed by FMEAs and provide these as input to future FMEA teams.

Management Plays a Key Role in Establishing and Supporting an Effective FMEA Process 

Individual FMEA practitioners can do their very best to perform FMEAs correctly, but there are certain vital activities that are the proper role of management to implement an effective FMEA process. Without these management-supported steps, FMEAs can flounder and miss the mark. These include establishing the strategy, providing the resources, implementing reviews of high-risk issues, supplier management, FMEA quality audits, integrating FMEAs with other businesses process, and providing the right FMEA software. Chapter 11 outlines the best practices of successful companies in achieving uniformly great results with FMEAs and explains some of the common FMEA implementation mistakes and how to avoid them. Chapter 16 shows how to select the right FMEA software that optimizes FMEA team effectiveness.

Support the Natural Passion and Energy of Employees to Achieve Trouble-Free Products 

FMEAs have had a reputation for being long, drawn out, and uninteresting. This does not have to be the case and it is hoped that this book will change that reputation where it exists. Every person in a company or organization wants to support safe and trouble-free designs and processes. By following the steps in this book, everyone involved with FMEAs can be part of a...